Require Out-of-State Pharmacy Inspections

Title of bill

An act to amend the education law, in relation to requiring non-resident pharmacy, manufacturing, wholesale or outsourcing facilities that ship, mail or deliver prescription drugs or devices to other establishments, authorized prescribers and/or patients residing in New York to be inspected within two years of application and demonstrate compliance with all standards of the verified pharmacy program administered by the National Association of Boards of Pharmacy

Purpose

This bill would amend the education law in order to require non-resident pharmacies that ship compounded sterile pharmaceutical products to New York State patients to meet additional requirements, to assure equivalence to those establishments within New York State and thereby assure greater public protection.

Summary of provisions

Section 1. Amends education law section 6808-b to increase requirements for non-resident pharmacies registered by the education department through its Board of Pharmacy, to submit evidence that they meet standards equivalent to registered establishments located within New York State and subject to oversight, including on sigh inspection, by the department.

Section 2. Amends education law section 6808-b to require every New York pharmacy to purchase or obtain prescription drugs and devices from approved entities.

Section 3. Provides for the effective date.

Justification

In 2012, there was a national outbreak of fungal meningitis ultimately linked to injections from a compounding pharmacy in the state of Massachusetts. Ultimately, this outbreak caused by the tainted compounded medicine include 64 fatalities, 732 sickened by infections and a number of others who live with chronic pain as an aftermath of the exposure to the tainted product. Investigators uncovered severely sub-standard conditions at the compounding center. Prior to 2012, the issue of bad actor compounders was on the Food and Drug Administration's (FDA) radar and there were concerns expressed that compounders are less stringently regulated than other drug makers, however, FDA resources are not able to physically inspect all locations and therefore they rely on customer complaints which is not a proactive means to protect the public.

In New York State, pharmacies are licensed, inspected and monitored by the New York State Board of Pharmacy in order to ensure safe supply of compounded prescription medicine. That applies to only pharmacies registered in New York State, therefore, for non-resident pharmacies, oversight is left to the state of origin which may or may not have the standards that New York State requires and New York State has limited ability to inspect and monitor these pharmacies. In response to this concern, the National Boards of Pharmacy (NABP), working with its member boards of pharmacy from across all states, including New York, developed an accreditation process for compounding pharmacies called Verified Pharmacy Program (VPP). VPP provides a trusted source among all state boards of pharmacy across the country to verify that VPP certified pharmacies are compliant with non-sterile compounding and sterile compounding practices are based on USP Chapters 795 ad 797, respectively, which is the federal standard. Initial verification includes a full review of the pharmacy's practice as well as an onsite physical visit. Additionally, after inspection and certification, pharmacies are subject to an ongoing compliance program which includes at a minimum onsite inspections and reporting.

Passage of this bill will ensure that patients receiving compounded prescriptions from other states are meeting a minimal standard of care to protect them from unfortunate events such as the Massachusetts contamination event.

Legislative history

New bill.

Fiscal implications

None

Effective date

This act shall take effect one year after it shall become a law.